Kornimate/medical-research-clean huggingface dataset:
double-blind follow-on safety study of hzt-501 (ibuprofen 800 mg/famotidine 26.6 mg) in subjects who have completed participation in hz-ca-301 (nct00450658) or hz-ca-303 (nct00450216)

Conditions: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Summary: the purpose of this study is to evaluate the safety of long-term treatment with hzt-501.

subject who have completed the 24-week treatment period of horizon protocol hz-ca-301 or hz-ca-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an nsaid for the next 6 months will receive treatment with the same study medication received while participating in hz-ca-301 or hz-ca-303. study with completed results acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * expected to continue to require daily administration of an nsaid for at least the coming 6 months. * subject completed the 24-week treatment period of either horizon protocol hz-ca-301 or hz-ca-303 exclusion criteria: * subject didn't meet all of the inclusion and exclusion criteria for horizon protocol hz-ca-301 or hz-ca-303 * subject developed or experienced any of the following while on either hz-ca-301 or hz-ca-303 * malignant disease of the gastrointestinal tract * erosive esophagitis * clinically significant cardiac, renal or hepatic disease * uncontrolled diabetes * positive pregnancy test on study day 0 * please note that there are other additional criteria. the study center will determine if you meet all of the criteria.
aud biomarkers study (proteomic and genomic analysis of biospecimens)

Conditions: Oncology; Hematologic Malignancy; Gastro-Intestinal Disorder; Autoimmune Diseases; Pregnancy Related; Infectious Disease; Cardiovascular Diseases; Genitourinary Disease; Renal Disease

Summary: study purpose: to explore the entire spectrum of proteomic and genomic changes (amongst others) involved in diseases and in healthy/control populations. the study is designed to discover biomarkers, develop and validate diagnostic assays, instruments and therapeutics as well as other medical research. specifically, researchers may analyze proteins, rna, dna copy number changes, including large and small (1,000-100,000 kb) scale rearrangements, transcription profiles, epigenetic modifications, sequence variation, and sequence in both diseased tissue and case-matched germline dna from subjects.

the primary objective of this study is to collect high-quality tissue, whole teeth, and biofluid specimens, and associated clinical data from consented subjects. the secondary objective of this study is to test specimens and associated clinical data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess rna and dna integrity or degradation, and provide overall quality control evaluations.

Eligibility criteria:
inclusion criteria: 1. subject shall be at least 18 years of age, or higher if required by applicable law. 2. subject's clinical data shall be relevant to the study in which he/she is participating. 3. subject shall understand and voluntarily sign the icf prior to the study participation. if the subject is illiterate, the witness must sign the icf (see 5.6. for details). if the subject is incapable of consenting himself/herself, the legally authorized representative must sign the icf (see 5.6. for details). 4. subject shall meet any other additional inclusion criteria specified in appendices to this protocol, or in additional written instructions of the sponsor. 5. subject shall be able to donate the requested specimen(s) without compromising his/her current health status. exclusion criteria: 1. younger than 18 years of age, or higher if required by applicable law. 2. the individual is incapable of understanding the items listed in the icf and the consent process unless consented by the legally authorized representative. 3. prisoner
safety and effectiveness of the rhciii-mpc biosynthetic cornea in patients requiring anterior lamellar keratoplasty

Conditions: Leukoma

Summary: in this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type iii collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.

recently developed and passed extensive pre-clinical testing collagen-phosphorylcholine(rhciii-mpc) corneal substitute will be implanted in patient's corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of cornea is removed, either manually or with assistance of femtosecond laser, it will be substituted with proposed transparent implant. control patients with same condition will be grafted with human donor cornea using the same surgical technique. the investigators will test the safety and the effectiveness of developed biosynthetic corneas. overall 20 patients are planned to recruit. they will be randomized in two groups - 10 patients will undergo rhciii-mpc cornea implantation, another 10 will be impanted with human donor cornea. the patients will be follow-uped for 12 months.

Eligibility criteria:
inclusion criteria: * subjects must sign and be given a copy of the written informed consent form. * subjects with best corrected distance visual acuity +1.0 logmar or worse as a result of corneal scar due to infection, injury or keratoconus in the operative eye. * subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery. exclusion criteria: * subjects with severe or life-threatening systemic disease. * subjects with uncontrolled hypertension. * subjects with uncontrolled diabetes or insulin-dependent diabetes. * subjects with glaucoma in either eye. * subjects with marked microphthalmos or aniridia in either eye. * subjects with any other serious ocular pathology, serious ocular complications at the time of surgery underlying serious medical conditions, based on the investigator's medical judgment. * subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

Keywords: keratoplasty bioengineered cornea donor cornea
bi 6727 (volasertib) randomised trial in ovarian cancer

Conditions: Ovarian Neoplasms

Summary: this is an international, randomized phase ii trial. the aim is to assess the efficacy and the safety of bi 6727 versus investigator's best choice single agent cytotoxic in recurrent third and fourth lines platinum resistant/refractory ovarian cancer. 100 patients will be randomised at the study entry to receive either bi 6727 (arm a: 50 patients) or non-platinum single agent cytotoxic (arm b: 50 patients) treatment will be continued until disease progression or unacceptable toxicity. primary endpoint: disease control rate at week 24 according to response evaluation criteria in solid tumours version 1.1. secondary endpoints: efficacy (progression free survival, overall survival, biological tumour response, biological progression free survival assessed by serum ca 125 according to gynecologic cancer intergroup criteria, safety according to the nci ctcae v.3, disease symptoms control assessed by the eortc qlq-c30, qlq-ov28 and individual symptoms questionnaires, pharmacokinetics of bi 6727. others endpoints: biomarkers and pharmacogenetics analysis (optional)


Eligibility criteria:
inclusion criteria: 1. confirmed recurrent epithelial ovarian carcinoma, peritoneal carcinoma or fallopian tube carcinoma. 2. platinum resistant or platinum refractory disease. 3. eastern collaborative oncology group performance status \< = 2. 4. life expectancy \> = 3 months. 5. at least one measurable lesion (response evaluation criteria in solid tumours version 1.1). 6. adequate hepatic, renal and bone marrow functions. 7. signed written informed consent prior to admission to the study. exclusion criteria: 1. contre-indications for cytotoxic treatment according to the summary of product characteristics (arm b). 2. clinical evidence of active brain metastasis or leptomeningeal involvement. 3. other malignancy currently requiring active therapy. 4. qtc prolongation according to fridericia formula deemed clinically relevant by the investigator (e.g., congenital long qt syndrome, qtc according to fridericia formula \> 470 ms). 5. hypersensitivity to one of the trial drugs or the excipients. 6. serious illness or concomitant non- oncological disease. 7. systemic anticancer therapy within 4 weeks before the start of the study. 8. evidence of ileus sor sub ileus.
a comparison of stryker's tritanium posterior lumbar cage and peek implant

Conditions: Degenerative Disc Disease; Degenerative Scoliosis

Summary: the purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with stryker's tritanium® posterior lumbar cage or the unilif peek implant.

this study protocol intends to examine the difference in efficacy between the tritanium posterior lumbar cage and the unilif peek implant with respect to how long it takes to achieve fusion of the spine. study participants will undergo a transforaminal lumbar interbody fusion (tlif) surgery and return for ct and x-ray follow-up to measure the degree to which fusion has been achieved. survey methodology to assess perceived pain, level of disability, and quality of life will also be used to measure the differences between groups on these components.

Eligibility criteria:
inclusion criteria: * subject is skeletally mature * subject has one or more of the following diagnoses: 1. degenerative disc disease (ddd) at one level or two contiguous levels from l2 to s1 a. ddd may include up to grade 1 spondylolisthesis at the involved level(s) 2. degenerative scoliosis for which the interbody fusion device will be used as an adjunct to fusion * subject has received 6 months of non-operative therapy * subject understands the conditions of enrollment and is willing to sign and date the informed consent * subject agrees to comply with visit schedule and study assessments * provision of signed and dated informed consent form * subject stated willingness to comply with all study procedures and availability for the duration of the study * subject is in good general health as evidenced by medical history exclusion criteria: * subject is obese (bmi \> 40) * subject is sensitive to titanium materials * subject has an active infection at the operative site * subject has marked local inflammation * subject has any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, bone absorption, osteopenia, tumors involving the spine, active infection at the site, or certain metabolic disorders affecting osteogenesis * subject has any mental, trauma, or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care * subject has any open wounds * subject is pregnant or plans to become pregnant during the course of the study * subject has inadequate tissue coverage over the operative site. * subject has an neuromuscular deficit which places an unsafe load on the device during the healing period * subject has any condition of senility, mental illness, or substance abuse * subject has any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (wbc), or marked left shift in the wbc differential count. * subject has prior fusion at the levels to be treated * subject is incarcerated
impact of high-dose pretreatment of rosuvastatin in patients with acute coronary syndrome following off-pump coronary artery bypass: results from the hirop-acs (high-dose pretreatment of rosuvastatin during off-pump coronary bypass in acute coronary syndrome) study

Conditions: A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.

Summary: periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions. -objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass (opcab) in patients with acute coronary syndrome. study design * prospective, double-blinded, single-center study of each 117 subjects enrolled * subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively. * eligible subjects will be randomized 1:1 to a) high-dose rosuvastatin (n=117) vs. b) placebo (n=117). * the amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total * all subjects will undergo opcab procedure. - the primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups


Eligibility criteria:
inclusion criteria: * the presence of acute coronary syndrome, including unstable angina, acute non-st elevation myocardial infarction * age of 19 years or older * a need for isolated surgical myocardial revascularization * patients with signed informed consent exclusion criteria: * patients with combined surgery with coronary bypass grafting * on-pump conversion * patients with any increase in liver enzymes * patients with history of liver or muscle disease. * patients with moderate renal dysfunction (creatinine\>2.0mg/dl) or need for dialysis * re-do surgery * urgent/emergent surgery

Keywords: statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome
automatic oxygen titration with o2matic® to patients admitted with covid-19 and hypoxemic respiratory failure

Conditions: Covid19; Hypoxemic Respiratory Failure; Hypoxemia

Summary: patients with coronavirus disease (covid-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. guidelines recommend controlled oxygen, for most patients with a recommended interval of spo2 between 92 and 96 %. we aimed to determine if closed-loop control of oxygen was feasible in patients with covid-19 and could maintain spo2 in the specified interval.

patients with coronavirus disease (covid-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. guidelines recommend controlled oxygen, for most patients with a recommended interval of spo2 between 92 and 96 %. we aimed to determine if closed-loop control of oxygen was feasible in patients with covid-19 and could maintain spo2 in the specified interval. patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with covid-19. closed-loop controlled oxygen was delivered by o2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of spo2 measured by pulse oximetry. lung function parameters were measured at admission.

Eligibility criteria:
inclusion criteria: * older than 18 years * positive covid-19 pcr analysis in pharyngeal swab or in tracheal secretion * need oxygen supply to maintain spo2 ≥ 92 % * able to comply with continuous measurement of spo2 by pulse oximetry. exclusion criteria: * need of oxygen supply \> 10 liters/min at admission

Keywords: o2matic closed-loop
effects of urocortins on forearm arterial blood flow in healthy volunteers (protocol 3)

Conditions: Vascular Disease; Heart Disease

Summary: impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research. urocortins are proteins that appear to increase blood flow and heart pumping activity. there has been particular interest in the role of urocortins 2 \& 3 (subtypes of urocortins) in heart failure. in this study, we will examine the effects and mechanisms of urocortins 2 \& 3 on forearm blood flow and release of natural blood clot dissolving factors in the forearm circulation of healthy volunteers. in particular, we look at the endothelial mechanisms of vasodilatation of urocortin 2 and 3. in this study, we will look at the role of the lining of the blood vessel (endothelium) in response to urocortin types 2 and 3. we hypothesise that urocortins 2 \& 3 act via the endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen activating factor (blood clot dissolving factor). we also hypothesise that urocortins have a role in maintaining the normal baseline level of blood flow in forearm arteries. in addition to the above, we will also look at the effect of temporarily blocking the effect of urocortins, using a specially designed blocker drug (astressin 2b). utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility criteria:
inclusion criteria: * healthy male volunteers between 18 - 65 years (inclusive) exclusion criteria: * lack of informed consent- age \ 65 years * current involvement in a clinical trial * severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure * smoker * history of anaemia * recent infective/inflammatory condition * recent blood donation (prior 3 months) * positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines) * history of allergy to aspirin

Keywords: urocortin 2 urocortin 3 nitric oxide plethysmography forearm blood flow vascular heart failure endothelium cyclo-oxygenase pathway edhf
remote physiotherapy to protect physical health in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: duchenne muscular dystrophy (dmd) is a progressive genetic neuromuscular disease characterized by progressive loss of motor function, respiratory failure, and cardiomyopathy required regular physiotherapy. with the outbreak of the pandemic rehabilitation centers that make up the weekly physiotherapy routine of children with disabilities have slowed down or even stopped their activities. so dmd who have additional diseases such as respiratory muscle weakness, spinal deformity, obesity, and cardiac dysfunction have also been negatively affected. the 'telerehabilitation' method, which is well planned and prepared for the abilities and needs of patients and caregivers, is seen as a good option at this point. studies, reporting the feasibility and safety of telerehabilitation in joint replacement, multiple sclerosis, and post-operative conditions, report that the length of stay was reduced, there was access to the same level of service regardless of the distance, and there was no travel cost. despite these advantages, the framework and applicability of telerehabilitation programs have been investigated limited and not focused on effectiveness of telerehabilitation in patients with dmd. according to the current knowledge, telerehabilitation in dmd is a subject that needs to be investigated in terms of its benefits. so, in this study, it was aimed to show the telerehabilitation's feasibility and its effects on performance level, endurance, fall frequency, pulmonary functions, and satisfaction level with the program in individuals with dmd.


Eligibility criteria:
inclusion criteria: * able to communicate verbally and visually, * older than 5 years old exclusion criteria: * individuals who had undergone any surgical operations in the past 6 months, * had a severe cognitive and breathing impairment, * using mechanical ventilator continually or intermittent, * having febrile infection
ebus-tbna-rte vs radiography in staging of nsclc

Conditions: Lung Cancer

Summary: the purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by cp-ebus elastography for the first time, and to make a benign and malignant diagnosis.

the newly developed convex array can be used to identify the hardness of the lymph nodes and estimate the benign and malignant lymph nodes indirectly through the quantitative and visualized analysis of the elastic coefficient of the bronchus through the cp-ebus elastography mode. the purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by cp-ebus elastography for the first time, and to make a benign and malignant diagnosis. 120cases will be enrolled.compared with the commonly used methods to evaluate intrathoracic lymph node metastasis, the accuracy of chest ct and pet-ct were compared. the lymph node staging method and the final pathological gold standard of the three groups were compared, so as to verify the accuracy and clinical popularization of the bronchial ultrasound elastography mode.

Eligibility criteria:
inclusion criteria: 1. intrathoracic lymph node enlargement 2. ebus-tbna operation can be performed exclusion criteria: 1. unable to cooperate with the experiment

Keywords: cp-ebus ebus-tbna real time elasticity staging of lung cancer
survey of the anxiety associated with the covid-19 pandemic

Conditions: Anxiety Related to the COVID-19 Pandemic

Summary: the study aims to systematically examine various aspects of the anxiety associated with the covid-19 pandemic in germany. the data collection is carried out online with longitudinal repeated measurements.

the covid-19 pandemic is currently one of the greatest challenges for numerous countries - also for germany. in addition to its somatic and economic consequences, the psychological dimension of the coronavirus pandemic is discussed increasingly and is visible in public life - e.g. in the "pandemic-caused experience of threat", "loss of control" and "panic" of multiple people. the study examines the phenomenon of this "corona-related anxiety" in terms of epidemiological, clinical and psychosocial characteristics. it is investigated how "corona anxiety" affects people who already have an anxiety disorder or other mental illnesses as well as formerly mentally healthy people. it is also examined how media reporting and personal consequences of covid-19 are connected with corona-related anxiety and if there is a need for therapeutic support regarding corona-related anxiety. to answer these questions a longitudinal online survey targeting the general population in germany is carried out. the survey takes place all three weeks as long as the pandemic lasts and ends with one follow-up one year later.

Eligibility criteria:
inclusion criteria: * informed consent was given * age ≥ 18 * able to complete the questionnaire in german * country of residence: germany exclusion criteria: * if at least one of the inclusion criteria is not met

Keywords: anxiety pandemic corona-virus sars-cov-2 corona covid-19 public health mental health health mental disorders